Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)

Not Applicable

Completed

Conditions: Weight Loss
Obesity
Morbid Obesity

Registration Number: NCT04197336

Lead Sponsor: Johns Hopkins University

Brief Summary: The BEATLES study is an investigator-initiated, prospective, double-blinded, randomized, sham-controlled study that will assess the impact of bariatric embolization on the systemic levels of obesity-related hormones and, as a consequence, on weight loss. The goal of this study is to help treat obesity combining a lifestyle program and a minimally invasive, angiographic (i.e., through blood vessels) approach.

Detailed Description: The BEATLES study is an investigator-initiated, prospective, double-blinded, randomized, sham-controlled study that will assess the impact of bariatric embolization on the systemic levels of obesity-related hormones and, as a consequence, on weight loss. The goal of this study is to help treat obesity combining a lifestyle program and a minimally invasive, angiographic (i.e., through blood vessels) approach.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

Inclusion Criteria

Male or female, aged ≥21 and ≤70 years
Willing, able, and mentally competent to provide written informed consent
Obese patients with a BMI ≥35 kg/m2
Weight ≤400 lb
Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist is amendable to bariatric embolization, as assessed via 3D CT angiography
Suitable for protocol therapy, as determined by the interventional radiology investigator
Adequate hematologic (neutrophils>1.5x109/L, platelets>70x109/L, international normalized ratio (INR<1.5), hepatic (bilirubin≤2.0mg/dL, albumin≥2.5g/L), and renal (estimated glomerular filtration rate (GFR)>60milliliter mL/min. 1.73m2) function
For females of reproductive potential: agreement to use of highly effective contraception
for duration of study participation
Patients who have failed conservative weight loss therapies such as supervised low calorie diets combined with behavior therapy and exercise
Live or work within 65 miles of the enrolling institution in case a catastrophic post embolization event occurs

Exclusion Criteria

hemoglobin A1c greater than 8%
Patients who are currently taking either Insulin or sulfonylurea (medication changes are allowed)
Prior history of gastric, pancreatic, hepatic, and/or splenic surgery
Prior radiation therapy to the upper abdomen
Prior embolization to the stomach, spleen, or liver
Cirrhosis
Known portal venous hypertension
Active peptic ulcer disease
Significant risk factors for peptic ulcer disease, including daily NSAID use
Large hiatal hernia, defined as >5 cm in size
Active H. Pylori infection
Known aortic pathology, such as aneurysm or dissection
Renal insufficiency, as evidenced by an estimated glomerular filtration rate of <60 milliliter(mL)/min
Major comorbidity, such as active cancer, significant cardiovascular disease, or peripheral arterial disease
Pregnancy
Pre-existing chronic abdominal pain
Positive stool occult blood study
GI bleeding or bleeding diathesis within 5 years
Weight loss (intentional or unintentional) of more than or equal to 5% of body weight in the 6 months prior to randomization
A weight loss greater than 6lb during the weight management run- in
Use of anti-obesity medications in the 12 months prior to screening
Endoscopic findings that would preclude bariatric embolization (at the discretion of the study team)
History of gastric motility disorders or an abnormal nuclear gastric motility examination (to be performed in diabetic subjects only)
American Society of Anesthesiologists Class 4 or 5 (very high risk surgical candidates: class 4=incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study - this exclusion criterion exists, because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects
Inflammatory bowel disease
Autoimmune disease or HIV+
History of allergy to iodinated contrast media
Failure to comply with pre-procedure weight management "run-in", or other pre-procedural visits (specifically, participants must complete 80% of weight management and Lose It! Food tracking, and 100% of one-time visits, i.e. MRI, computed tomography angiography (CTA), endoscopy)
Applicability of any contraindication regarding patient's vasculature as per Instruction for Use
Inability to have an MRI scan (i.e., metal implants or claustrophobia)
Smokers/vape users/tobacco use
Active or new-onset endocrine disorders (stable disease acceptable)
Other unforeseen conditions that may make patients unsuitable for the procedure (study team discretion)

Exclusion Criteria (Psychiatric):

As determined by clinical judgment based on Clinical Interview, psychological/behavioral measures, medical records, previous mental health records/other collateral information (as available) and consistent with diagnostic and statistical manual of mental disorders (DSM) -5 criteria:
Diagnosis of severe mental illness (i.e., chronic psychotic spectrum disorders, clinically significant mood disorders) AND/OR one or more of the following:
Evidence of active relapse or active impairing symptoms (e.g., suicidal ideation, audio or visual hallucinations, paranoia, thought disturbance, severe impairment)
Evidence of minimal supports or limited adherence to ongoing mental health care
Failure to provide comprehensive aftercare plan that includes emergency plan for addressing future mental health relapse
History of treatment refractory mental illness/recurrent relapse (multiple suicide attempts or inpatient psychiatric hospitalizations in the past 5 years)
Within past 3 years: Inpatient psychiatric hospitalization
Within past 5 years: Suicide attempt
Declining to provide mental health records, a letter of support from mental health professionals, or consent for verbal consultation with mental health professionals when determined to be essential to evaluation.
Cognitive impairment, if judged to have
Limited capacity to make informed decision about procedure and inability to verbalize an understanding of the surgical procedure, risks and benefits.
Inability to demonstrate an understanding of the permanency of lifestyle change required
History of Anorexia or History of/Active Bulimia: If determined to be of low enough severity not to be a clear contraindication, minimum of 5 years abstinence from bulimia, current moderate to severe binge eating or night eating syndrome
Active or History of Substance Abuse with less than 5 years of abstinence
Current use of anti-tricyclic anti-depressants or steroids, psychiatric medications associated with weight gain.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Body Weight as Assessed by BMI (kg/m^2)	12 months	Efficacy of Bariatric Embolization procedure assessed by change in body weight as assessed by BMI.
Change in Body Weight (Pounds)	12 months	Efficacy of Bariatric Embolization procedure assessed by change in body weight (pounds)

Secondary Outcome Measures